BSD Science
Global revolution in the pharmaceutical industry
BSD Science has developed a groundbreaking oral drug delivery system that ensures the controlled release of lipid-active substances, thereby extending drug efficacy and minimizing side effects.
50% of funding target
Highlights
Highlights
The Groundbreaking Innovation that Allows Controlled Release of Lipid-Active Substances by Oral Administration
BSD Science developed a revolutionary controlled-release platform for oral administration of a variety of lipid-active ingredients in the pharma, medical cannabis, and dietary supplements industries. While the company's primary focus centers around cannabinoids, this is just the tip of the iceberg in terms of potential applications. At present, the market lacks an effective solution for the controlled-release of cannabinoids through oral administration, which are only available in immediate-release form—leaving patients with short-term effects, inconsistency in drug absorption, and side effects associated with excessive drug blood concentrations. BSD Science is ensuing a revolution in the field, by enabling fixed drug blood concentrations, prolonged duration of effect, and a significant decrease in adverse effects—all achieved through the convenience of user-friendly oral pills.
An Essential Asset for the Biggest Players in the Pharma Industry
Following the initial development for the medical cannabis industry, BSD Science's platform will address the continuous release of other lipid molecules for the pharma and dietary supplements industries. In this manner, the biggest pharma companies such as Pfizer, Merck, Novartis and Johnson & Johnson can utilize the company's development to significantly improve the efficacy of their lipid active ingredients products and user experience, as well as expand their target audience, by providing continuous release and absorption of their lipid-active ingredients using standard capsules or tablets.
Successful Results in Pre-Clinical Studies
Following their initial formulation development and in preparation for a full-scale human clinical study, BSD Science evaluated its system rigorously in a lab environment. The dissolution lab test showed excellent results, with a 12-hour consistent drug release profile using a range of dosages in different conditions simulating the different parts of the digestive system.
Subsequent to these successful lab outcomes, BSD Science conducted a proof-of-concept pharmacokinetic animal study, collaborating with Lahav CRO, (the largest GLP accredited CRO, for large animals in Israel). The study was performed on big animals (swine), where three final formulations were tested in comparison to an immediate release formulation. The results obtained from this study are highly promising, bolstering BSD Science's trajectory toward groundbreaking advancements in the field.
Patent Submission
BSD Science has submitted an international patent application (PCT) for controlled-release oral formulations of oil-soluble drugs and its innovative production technology. The application was written and submitted by The Reinhold Cohn Group ( the leading Intellectual Property consulting firm in Israel) after professional search was performed in order to verify the technological innovation and the patentability of the company's product
An Investment from the Medical Cannabis Company, Elixie, and Participation in the Ministry of Economy and Industry's Accelerator
BSD Science has recruited a significant investment from the medical cannabis company ELIXIE, which recognized the immense potential and great market need for the product, which will dramatically improve the service offerings to their customers. ELIXIE is also planning on signing a commercialization agreement following the company's clinical study.
Moreover, the company has participated in the Ministry of Economy and Industry's accelerator, Maof Tech, which provides a supportive professional envelope and guidance to tech startups all over Israel.
A Team with Extensive Knowledge and Experience in Drug R&D
BSD Science is led by a team of experts in the pharma and medical cannabis industries, that is familiar with the challenges and requirements of clinical studies and drug R&D. The company’s Founder and CEO, Yochai Yakovson, has more than 16 years of experience in senior R&D positions in the pharma industry, including Teva Pharmaceuticals, Dexcel Pharma and Intec Pharma Ltd,. Adi Bigger Hoggeg is the company's Clinical Manager, with over 20 years of experience and deep understanding of the complex planning and execution processes of clinical research, in preperation for the company's own clinical study. Finally, Yaron Shoob, a part of the company's Board of Directors, has a strong finance and business background and over a decade of experience in the medical cannabis arena. Yaron is the Founder and CEO of Elixie Ltd., a medical cannabis company interested in using BSD Science's development.
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Pitch
Pitch
Controlled-release drugs offer several significant advantages over conventional immediate-release formulations, making them a valuable asset in modern pharmaceutical developments. One of the key benefits is their ability to maintain a consistent and steady therapeutic level of the active pharmaceutical ingredient within the body, minimizing fluctuations and ensuring prolonged efficacy. This controlled and sustained drug release not only reduces the frequency of dosing but also enhances patient compliance, as fewer administrations are required. Moreover, controlled-release formulations can help mitigate potential side effects by reducing peak concentrations, making treatments more tolerable for patients. These formulations can be particularly advantageous and improve outcomes for conditions demanding prolonged exposure and stable, continuous blood levels. Nevertheless, the current technologies available on the market for oral administration enable the controlled release of water-soluble (hydrophilic) substances only, and not oil-soluble (lipophilic) substances, such as cannabinoids.
The hydrophilic environment along the digestive system is compatible with the prolonged release of water-soluble substances only, while oil-soluble substances are trapped within the matrix they are linked to, and therefore cannot be easily released over time. Furthermore, these lipophilic substances must be broken down by gastric enzymes and bile salts in the stomach and duodenum, in order to effectively absorb in the digestive system. A lipophilic drug which is released in the small intestine is not capable of becoming emulsified and efficiently absorbed.
The Need
The Need for the Controlled Release of Lipophilic Substances
The controlled release of lipophilic drugs presents a set of challenges stemming from the unique characteristics of these compounds. Ensuring precise control over the release of such substances, while maintaining steady therapeutic levels, demands sophisticated formulation strategies. Despite these challenges, successful oral controlled release of lipophilic drugs holds immense promise for improving therapeutic outcomes and patient compliance, driving research and innovation in drug delivery technologies.
The Need for the Controlled Release of Lipophilic Substances
Cannabinoids are the active ingredients naturally found in cannabis, which can also be synthetically formulated in a lab, and are known for their pain relief, calming qualities, and anti-inflammatory properties. These are highly lipophilic substances, which current administration methods include immediate release (IR) dosage forms such as smoking, inhalation, sublingual oil, buccal spray, and IR capsules. These lack prolonged drug efficacy and can lead to side effects associated with high blood concentration levels.
By delivering cannabinoids in a controlled and sustained manner, these formulations can provide prolonged relief for conditions like chronic pain, and anxiety, where consistent and stable dosing is crucial. Controlled release mechanisms enable a more balanced and gradual release of cannabinoids, reducing the risk of adverse effects associated with abrupt spikes in concentration. This approach also offers the advantage of enhancing patient compliance and convenience, as it reduces the frequency of dosing. Furthermore, for conditions requiring specific timing or extended duration of cannabinoid activity, such as chronic pain , sleep disorders or post-traumatic stress disorder (PSTD)- controlled release can maximize therapeutic efficacy. As opposed to smoking and vaping, oral administration via a standard pill, will also allow the elderly population and kids to clinically benefit from the substance.
The Solution
BSD Science addresses the existing market gap with a revolutionary controlled-release platform for lipophilic drugs using standard oral administration in the form of a pill. This system will enable the continuous release and absorption of oil-soluble substances, providing patients with steady drug blood concentrations, prolonged duration of effect, decrease in side effects, and higher treatment compliance among all populations. The innovative technology is suitable for a variety of oil-soluble molecules in the worlds of medical cannabis, pharma, and dietary supplements.
The Technology
BSD Science's one-of-a-kind patent-based technology that allows the prolonged release of the active ingredient over time, up to 24 hours, as well as prolonged absorption along the entire GI tract. Using the BSD platform enabled a flat and stable PK profile and cause long duration of effect and less adverse effects.
This unique innovation provides a double value, thus meeting the field's main challenges:
- Effective release of lipophilic substances - the lipophilic molecule is easily released from the matrix to the hydrophilic environment along the GI tract.
- Effective absorption of lipophilic substances - the drug is easily absorbed along the entire digestive system, without the need for any enzymatic activity or breakdown.
The final product is available in a capsule or tablet form, allowing standard oral administration. In addition, an immediate release fraction may be added to the final product, for an immediate effect, along with the continuous release.
Team
Team
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With over 16 years of experience in the R&D, project management, production processes and clinical trials fields, as well as senior positions in the pharma industry, including Teva Pharmaceuticals, Dexcel Pharma and Intec Pharma Ltd.
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A seasoned clinical expert, with deep knowledge and over 20 years of experience in the planning and execution of clinical research in leading pharmaceutical companies, including Intec Pharma Ltd. and IQVIA.
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With a strong finance and business background and over a decade of experience in the medical cannabis arena, Yaron‘s resume includes business and finance consulting positions, and he currently serves as the CEO of Elixie Ltd.—a medical cannabis startup.
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